TheraTogs Versus Reciprocal Electrical Stimulation on Children With Diplegic Cerebral Palsy: a Randomized Controlled Trial

NCT05702632 | Completed

• 1 other identifier: Approaches
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Children with diplegic cerebral palsy exhibit postural restrictions as a result of both primary and secondary brain damage impairments. One of the main goals of cerebral palsy rehabilitation is to improve balance and stability. As a result, the purpose of this study is to compare the effects of TheraTogs and reciprocal electrical stimulation on postural stability in children with diplegic CP.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

• postural stability

  overall stability indices had been measured by Biodex balance system

  3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Device: 1- Reciprocal electrical stimulation; Procedure: traditional physical therapy program

Group B

ACTIVE COMPARATOR

Device: TheraTogs orthotic treatment; Procedure: traditional physical therapy program

Interventions

1- Reciprocal electrical stimulation DEVICE

A specialized programmable electrical stimulation device was used (Uniphy is the manufacturer of Phyaction787; Uniphy, Eindhoven, the Netherlands). The device has two channels that can alternatively stimulate two opposing groups of muscles (reciprocate).

Group A

TheraTogs orthotic treatment DEVICE

A sleeveless top vest and two pairs of shorts with two thigh cuffs and limb cuffs each make up the TheraTogs strapping system which is applied to the children in the TheraTogs group. The TheraTogs suit is providing breathable, comfortable- Latex over the torso and thigh, as well as free toileting. For infection control and size fitting problems, participants are not allowed to share their TheraTogs with other patients. TheraTog's orthotic undergarment and strapping system were worn under their regular clothes, so it was neither distracting nor irritating.

Group B

traditional physical therapy program PROCEDURE

Facilitation of balance and gait training

Group A; Group B

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diplegic children of both sexes are between the ages of 8 and 12. The level of spasticity in the lower limbs ranged from grade 1 to grade +1 on the modified Ashworth scale (MAS). The levels of motor function were between levels I and II, according to the Gross Motor Function Classification System (GMFCS).

You may not qualify if:

• If they had no major medical issues, according to their medical report. Skin diseases and allergic reactions to the adhesive tape used in this study were excluded, as were any deformities that interfered with lower limb functions, children with pace- makers who were contraindicated by electrical stimula- tion, children with visual, auditory, or perceptual deficits, and children with seizures.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Eldoky, 11234, Egypt

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at faculty of physical therapy

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: January 27, 2023
• Study Start: July 15, 2022
• Primary Completion: September 8, 2022
• Study Completion: December 30, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

EG (1)